MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-04-01 for COOL FLOW IRRIGATION PUMP M-5491-02 CFP002 manufactured by Hei, Inc..
[1069661]
It was reported that during the procedure, the customer experienced high impedance readings on the stockert generator while using the hansen system. The maximum valves during the lesion were 30 watts, 147 ohms, and 48 degrees celsius. The rf energy was terminated when the impedance reading increased to 150 ohms. While customer was troubleshooting the high impedance readings, the patient's blood pressure dropped precipitously. The procedure was stopped and a pericardiocentesis drain was placed. The patient was ultimately transferred to the or where surgical repair of the basal left atrium was performed. Additional information obtained: the patient did well and fully recovered after surgery.
Patient Sequence No: 1, Text Type: D, B5
[8223047]
The biosense webster field service engineer (fse) contacted the customer with regards to this incident. The customer was of the opinion that the cool flow pump did not cause the adverse event, and it did not need to be evaluated by biosense webster. Customer used the cool flow pump in a subsequent procedure without any issues.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721752-2009-00005 |
| MDR Report Key | 1356312 |
| Report Source | 06 |
| Date Received | 2009-04-01 |
| Date of Report | 2009-03-02 |
| Date of Event | 2009-03-02 |
| Date Mfgr Received | 2009-03-02 |
| Date Added to Maude | 2009-04-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | GAIL HAPNER |
| Manufacturer Street | 15715 ARROW HIGHWAY |
| Manufacturer City | IRWINDALE CA 91706 |
| Manufacturer Country | US |
| Manufacturer Postal | 91706 |
| Manufacturer Phone | 9098398938 |
| Manufacturer G1 | HEI, INC. |
| Manufacturer Street | 4801 NORTH 63RD ST. |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COOL FLOW IRRIGATION PUMP |
| Generic Name | LPB PUMP, CIRCULATING-FLUID, LOCALIZED HEAT |
| Product Code | KQT |
| Date Received | 2009-04-01 |
| Model Number | M-5491-02 |
| Catalog Number | CFP002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEI, INC. |
| Manufacturer Address | BOULDER CO US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2009-04-01 |